Source: rwmalonemd.substack.com
Both Moderna and Pfizer/BioNTech SARS-CoV-2 vaccines are contaminated with plasmid DNA fragments which have not been removed during the current manufacturing processes. This proven fact has been acknowledged by the US FDA, Health Canada, and the European Medicines Agency. In yet another clear breach of informed consent and labeling requirements, this was not previously disclosed to physicians, public health officials, or patients. Furthermore, the presence of highly active promoter/enhancer DNA sequences (and fragments) derived from the SV40 virus, present in the Pfizer/BioNTech product, was not disclosed and discussed with either the public or to the regulatory agencies. This has also been clearly established. Prior FDA guidance concerning the closely related DNA vaccine technology cited the presence of such highly active regulatory sequences as being of particular concern due to potential insertional mutagenesis (integration).
Despite these facts, and contrary to both federal law (21 U.S. Code § 351 – Adulterated drugs and devices) and established FDA guidance (CPG Sec. 420.100 Adulteration of Drugs Under Section 501(b) and 501(c) of the Act. *Direct Reference Seizure Authority for Adulterated Drugs Under Section 501(b)*), in response to reporter questioning regarding this issue, the FDA has issued a categorical denial of adulteration and risk, stating that “no safety concerns related to the sequence of, or amount of, residual DNA have been identified.”
The claim that the FDA is required to take any of the authorized or approved mRNA COVID-19 vaccines off the market is false. With over a billion doses of the mRNA vaccines administered, no safety concerns related to the sequence of, or amount of, residual DNA have been identified. With regard to the FDA-approved mRNA vaccines, available scientific evidence supports the conclusion that they are safe and effective.
At best, this is willful blindness. As previously discussed at length (with peer reviewed references), such short DNA fragments (including “oligonucleotides”) are associated with a high risk of integration, otherwise known as insertional mutagenesis, which is a well characterized form of genotoxicity. If these “vaccines” were reviewed by FDA as gene therapy products, which in fact they are gene therapy technology employed for the purpose of eliciting an adaptive immune response against an encoded antigen, rigorous genotoxicity (including insertional mutagenesis) studies would have been required prior to use in humans. If these were “DNA vaccines” rather than modified-mRNA vaccines, rigorous genotoxicity (including insertional mutagenesis) studies would also have been required prior to use in humans. But apparently there is something magical about inclusion of modified-mRNA together with DNA fragments in these highly active lipid nanoparticle nucleic acid delivery formulations which leads the FDA to conclude that there is no genotoxicity risk.
Of note is that there is no documentation of DNA fragment genotoxicity studies having been performed by Pfizer/BioNTech or Moderna or FDA itself to assess the risk profile of these highly active non-viral delivery formulations when co-formulated with both modified mRNA and DNA fragments. Clearly, given the established scientific literature and prior established regulatory precedent involving DNA vaccine insertional mutagenesis/integration risk, a prudent and proactive regulatory authority would have developed data to support a data-based threshold for DNA fragment contamination. But by all appearances, no such data are available. The most well-documented risks associated with such potential insertional mutagenesis are cancer (in the case of stem and somatic cells, particularly hematopoietic lineage cells) and birth defects. As these highly active modified mRNA (plus DNA fragment) lipid nanoparticles are known to cross the placenta and to localize to ovarian tissue, the potential for birth defects would seem to be of particular regulatory interest and concern.
However, despite global reports of unusually aggressive cancers (high mitotic rates and unusually rapid clinical progression) arising in patients administered these products, and the established fact that the CDC VAERS system does not support capturing longer term safety data on these products, the FDA remains willfully ignorant and in denial of these risks. Furthermore, despite the repeated propaganda line of “safe and effective”, the FDA refuses to qualify these subjective terms. What is actually meant by “safe”? For products which do not prevent infection, replication, or spread of SARS-CoV-2 virus? And which do not prevent severe clinical illness or death from COVID disease? And for which the currently dominant circulating HV.1 (pango designation) SARS-CoV-2 strain is almost completely resistant to neutralization by antibodies elicited after administering the currently approved “booster” vaccine? Previously, with disease associated with certain SARS-CoV-2 strains, the FDA and CDC have asserted that prior versions of the modified mRNA/DNA fragment vaccines reduce risks of severe disease or death, but those assertions (whether true or artifactual) are now irrelevant as those “vaccine” products are no longer available, and those viral strains are extinct. Furthermore, many researchers have demonstrated that, even in those historic cases, after some period of time those so dosed with these products become MORE likely to develop severe disease or death relative to unvaccinated patients (most of whom have acquired natural infection with resulting potent and diversified immunity.
Despite these well established facts, the FDA continues to substitute hope for data, willful ignorance for careful risk analysis, and issues what can only be regarded as propaganda regarding both the safety and effectiveness of these products.
Unfortunately for the FDA, the modified mRNA manufacturer Moderna clearly acknowledges the risks of genotoxicity associated with delivered DNA. In the issued US Patent #US2019/0240317 A1 (see image above) titled “HPIV3 Vaccines”, Moderna provides the following text:
[0012] Deoxyribonucleic acid (DNA) vaccination is one technique used to stimulate humoral and cellular immune responses to foreign antigens, such as hMPV antigens and/or PIV antigens and/or RSV antigens. The direct injection of genetically engineered DNA ( e.g., naked plasmid DNA) into a living host results in a small number of its cells directly producing an antigen, resulting in a protective immunological response. With this technique, however, comes potential problems, including the possibility of insertional mutagenesis, which could lead to the activation of oncogenes or the inhibition of tumor suppressor genes.
Note that Moderna considers even “naked” plasmid DNA (with no added highly active lipid nanoparticle formulation agents) to place patients at risk of insertional mutagenesis, and associated cancer risk (ergo “activation of oncogenes or the inhibition of tumor suppressor genes”). Precisely the integration and genotoxicity risks which I previously highlighted. No surprise, as these are risks which I identified as providing the most compelling support for the use of mRNA for vaccines and genetic medicines in my original patent disclosures and subsequent issued patents from the late 1980s.
Moderna further elaborates on these risks in the summary statement for this patent….